The Alcohawk Precision™ is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.

AI/ML Overview

Here's a breakdown of the Alcohawk Precision™ device's acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Feature	Acceptance Criteria (Predicate Device: AlcoMate CA2000 K041334)	Reported Device Performance (Alcohawk Precision™)	Meets Criteria?
INDICATION For USE	Intended to measure alcohol in human breath; measurements used in diagnosis of alcohol intoxication.	SAME	Yes
MODE	Breath Alcohol Concentration	SAME	Yes
PRACTITIONER USE	Over the Counter	SAME	Yes
DISPLAY	3 Digit LED	4 Digit LED	N/A (Improvement)
POWER SOURCE	9 Volt Alkaline Battery	SAME	Yes
BATTERY LIFE	300 Tests	100-300 tests	Yes (within range)
Measurement Range	.00-.40%	SAME	Yes
Accuracy	+/-0.01%	SAME (+/- .009%)	Yes (meets or exceeds)
TYPE OF SENSOR	Semiconductor-Oxide Sensor	SAME	Yes
ANATOMICAL SITE	Mouth	SAME	Yes
Mouthpiece	Replaceable	SAME	Yes
Warm Up Time	20 Seconds	15-60 Seconds	Yes (within range)
Blowing Time	5 Seconds	SAME	Yes
DOT Approval	YES	YES	Yes
Construction	Plastic case with internal circuit board	SAME	Yes
SIZE	5" x 3 ½"	4.25" x 2.75"	N/A (Difference in physical attributes)
WEIGHT	200 grams	130 grams	N/A (Difference in physical attributes)

Note: The 'N/A' for some features indicates that while there are differences, they are either improvements (e.g., 4-digit LED display) or physical attributes that do not directly relate to the device's functional performance or safety compared to the predicate, and thus do not constitute a failure to meet acceptance criteria in the context of substantial equivalence. The key functional criteria like indication for use, accuracy, measurement range, and sensor type are either identical or meet/exceed the predicate.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "user testing data" and "bench tests", "DOT testing", but the specific number of participants or tests for the "clinical trial" is not provided.
- Data Provenance: The document does not specify the country of origin for the data. The "user testing data" combined with a "clinical trial" suggests prospective data collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The document mentions that the clinical trial results were "comparable to those provided by a professional unit administered by a trained observer." This implies the ground truth was established by "trained observers" using "professional units," but their specific qualifications (e.g., medical professionals, certified breath alcohol technicians) are not detailed.
Adjudication method for the test set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the device could "obtain results that were comparable to those provided by a professional unit administered by a trained observer," suggesting a comparison against a reference standard.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a standalone breath alcohol detector, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex data by radiologists/experts. Therefore, an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the device is inherently a standalone device. The "clinical trial" was performed to establish that users could properly use the device and the device would obtain "comparable results" to a professional unit. This implies evaluating the device's performance directly, independent of human interpretive assistance (beyond basic user operation). The accuracy specified (+/- 0.009%) is for the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by measurements from "a professional unit administered by a trained observer." This suggests a reference measurement from a validated, higher-standard breath alcohol testing system. It is a form of reference standard comparison rather than expert consensus on images or pathology.
The sample size for the training set:
- Not applicable. This device is a hardware-based sensor system with a semiconductor oxide sensor, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's operation is based on established physical and chemical principles, not learned patterns from data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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1(09)3188

EXHIBIT 2

510(k) Summary Q3 INNOVATIONS, LLC 1520 Oakbrooke Lane Eagan, MN 55122 Telephone: 651-762-5728 Fax: 651-905-3954

November 2, 2004

Contact: Brian Eddy, CEO/CFO

Identification of the Device: 1.
Proprietary-Trade Name: Alcohawk Precision™ Digital Alcohol Detector Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
Equivalent legally marketed devices AlcoMate CA2000™ Digital Alcohol Detector 2. manufactured by Han International, K041334
Indications for Use (intended use) : The device is intended to measure alcohol in the human 3. breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Description of the Device: The Alcohawk Precision™ is designed to measure deep lung air to 4. test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device.

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Feature	AlcoMate CA2000 K041334	Alcohawk Precision™
INDICATION For USE	The device is intended to measurealcohol in the human breath.Measurements obtained by thisdevice are used in the diagnosis ofalcohol intoxication.	SAME
MODE	Breath Alcohol Concentration	SAME
PRACTITIONER USE	Over the Counter	SAME
DISPLAY	3 Digit LED	4 Digit LED
POWER SOURCE	9 Volt Alkaline Battery	SAME
BATTERY LIFE	300 Tests	100-300 tests
Measurement Range	.00-.40%	SAME
Accuracy	+/-0.01%	SAME (+/- .009%)
TYPE OF SENSOR	Semiconductor-Oxide Sensor	SAME
ANATOMICAL SITE	Mouth	SAME
Mouthpiece	Replaceable	SAME
Warm Up Time	20 Seconds	15-60 Seconds
Blowing Time	5 Seconds	SAME
DOT Approval	YES	YES
Construction	Plastic case with internal circuitboard	SAME
SIZE	5" x 3 ½"	4.25" x 2.75"
WEIGHT	200 grams	130 grams

6. Substantial Equivalence Chart

7. Conclusion

After analyzing bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data, it is the conclusion of Q3 INNOVATIONS, LLC that the Alcohawk Precision™ is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with a bird-like figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus.

FEB - 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

03 Innovations, LLC c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, IL 60015

K043188 Re:

Trade/Device Name: AlcoHawk™ Precision Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: November 5, 2004 Received: November 26, 2004

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ____AlcoHawk™ Precision

Intended to measure alcohol in the human breath. Indications For Use: Maloutions For Society - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benam
Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety Page 1 of 1

510(k) K043188

Regulation Number and Section

§ 862.3050 Breath-alcohol test system.

(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.